Clinical Study Protocols: The Pillars of Clinical Development
Welcome to the 2023 Medical Writing Supplement developed as a collaboration between Samedant Ltd and Trilogy Writing & Consulting and published as part of the Winter edition of International Clinical Trials (ICT).
In this edition, we focus on the importance of well-written clinical study protocols as pillars in the pharmaceutical industry’s search for efficiencies and reduced drug development time. Our aim is to raise awareness of the far-reaching impact that well-crafted protocols can have on study quality and drug development speed.
The opening article by Julia Forjanic Klapproth highlights the critical role of the clinical study protocol as the cornerstone of a clinical study, and the negative impact poorly written protocols can have on study outcomes. As study complexity increases year on year, Walther Seiler and Jeff Garwin explore the fundamental importance of harmonised standards and protocol templates in ensuring high-quality protocols. Natalie King, Daniela Nakagawa, Jonathan Mackinnon, and Lisa Chamberlain James provide insights into some of the emerging protocol challenges and how they can be overcome.
You can read the magazine here.
Medical Writing - A Bold New Path: The Future Awaits Us
The second edition of Trilogy’s special edition magazine, Medical Writing – A Bold New Path: The Future Awaits Us, was published at the beginning of 2020. Once again, Trilogy Writing & Consulting partnered with International Clinical Trials to create this captivating magazine with articles written by thought leaders from across the pharmaceutical and medical writing industry. Presidents of both the European Medical Writers Association and the American Medical Writers Association have welcomed this special edition by providing a foreword in which they express their enthusiasm over this initiative.
This new edition is focused on what being a medical writer today means and gives some insights into where the world of medical writing is headed.
We hope this magazine and the articles in it encourage medical communicators around the world to start thinking about the future of medical writing and how we can use these changes to our advantage.
Medical Writing: The Backbone of Clinical Development
In the end of 2016, experts from the world of medical writing were brought together to support an industry-wider initiative – a special edition magazine on Medical Writing. It was edited by one of Trilogy’s Senior Partners, Julia Forjanic Klapproth.
This special edition is meant to increase the general awareness of the need for good documentation on the one hand and to provide good medical writing practices and tricks of the trade on the other hand. It is intended to have lasting value as a reference book for the target audience – medical writers and everyone in the pharmaceutical industry working with medical writers.
Both the FDA and the EMA have welcomed this special edition by providing a foreword in which they express their enthusiasm over this initiative.